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GUIDANCE DOCUMENT

Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic May 2020

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2008-D-0610
Issued by:
Guidance Issuing Office
Human Foods Program
Center for Biologics Evaluation and Research
Center for Devices and Radiological Health
Center for Drug Evaluation and Research

This guidance provides recommendations to industry regarding postmarketing adverse event reporting for drugs, biologics, medical devices, combination products, and dietary supplements during a pandemic. FDA anticipates that during a pandemic, industry and FDA workforces may be reduced because of high employee absenteeism while reporting of adverse events related to widespread use of medical products indicated for the treatment or prevention of the pathogen causing the pandemic may increase. The extent of these possible changes is unknown. This guidance discusses FDA’s intended approach to enforcement of adverse event reporting requirements for medical products and dietary supplements during a pandemic.

 

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5630 Fishers Lane, Rm 1061
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All written comments should be identified with this document's docket number: FDA-2008-D-0610.

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